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Louisville,
Kentucky40292

Purpose:

To assess the response for subjects with pancreatic cancer that have undergone surgical
resection and treatment with a vaccine given with or without chemotherapy and
chemoradiation.

Study summary:

Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most
patients diagnosed with pancreatic cancer continue to die from their disease in a very short
period of time. The primary reason for this is the short progression time of the disease; in
fact, most patients with pancreatic cancer have symptoms at the time of the diagnosis.
Moreover, lack of any single agent or procedure to have any significant impact on long term
survival rates further contributes to poor prognostic outcomes observed with this disease.
These reasons are the major causes of cancer progression that are usually discussed when
considering treatment options for patients with disease that continues to grow and spread.
However, another important part of the body should be considered-- the immune system.
Scientists have clearly shown that pancreatic cancer cells as well as other cancer cells
produce a number of abnormal proteins or abnormal amounts of certain proteins not found in
normal cells. Normally one would expect a patient to develop an immune response against
these abnormal proteins found in their cancer and attack them much the way we would fight
off an infection from a foreign bacteria or virus. However, for reasons that scientists do
not fully understand, the immune system fails to respond to these abnormal proteins and does
not attack the cancer cells. This human clinical trial proposes a new way to make the immune
system recognize the cancer and encourage it to attack the cancer cells.
Many people are familiar with the idea of transplants between people of organs like the
kidneys or heart. When an organ transplant between two people is completed one of the
problems that can occur is rejection of the donated organ by the recipient. This can occur
because the immune system of the patient who receives the organ attacks the donated organ.
If you were to attempt to transplant a pig heart to a human the rejection would be
dramatically stronger than when organs are transplanted between two people. This is partly
because lower animals express sugar-protein patterns on the surface of their cells that
humans do not. In fact, our immune systems can quickly recognize tissues from lower mammals
such as the pig or the mouse and destroys them.
In this project, we propose to put a mouse gene into human pancreatic cancer cells that
produces these abnormal sugar patterns and stimulates the immune system to attack the
pancreatic cancer. This strategy works well to kill other human cancer cells in the
laboratory, but it needs to be tried in pancreatic cancer patients to see if it will be
effective. We propose to test this new treatment in patients with pancreatic cancer who have
undergone tumor resection to see if it can stop or slow recurrence of tumors in these
patients. Patients will be injected with an anti-tumor vaccine consisting of a mixture of
two types of dead human pancreatic cancer cells that have been genetically altered to
express the mouse gene responsible for making this abnormal sugar-protein on the cells.

Criteria:

Inclusion Criteria:
- A histological diagnosis of adenocarcinoma of the pancreas. The patient's pathology
must be reviewed and confirmed by the clinical site's Pathology Department.
- AJCC Stage I or II Pancreatic carcinoma. Patients must have undergone surgical
resection for the tumor and extent of resection must be either R0 (complete resection
with grossly and microscopically negative margins or resection) or R1 (grossly
negative but positive microscopically margins of resection).
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Serum albumin ≥ 2.0 gm/dL.
- Expected survival ≥ 6 months.
- Subjects must have a negative serology for HIV prior to entering study.
- Subjects must be able to take in ≥ 1500 calories daily.
- Adequate organ function including:
- Marrow: WBC ≥3000/mm3 and platelets ≥100,000/mm3.
- Hepatic: serum total bilirubin ≤ 2 x ULN mg/dL, ALT (SGPT) and AST (SGOT) ≤3 x upper
limit of normal (ULN).
- Renal: serum creatinine (sCr) ≤2.0 x ULN, or creatinine clearance (Ccr) ≥30 mL/min.
- First vaccination must be within 6 weeks after surgery.
- Patients must have the ability to understand the study, its inherent risks, side
effects and potential benefits and be able give written informed consent to
participate.
- All subjects of child producing potential must agree to use contraception or
avoidance of pregnancy measures while enrolled on study and receiving the
experimental product, and for one month after the last immunization.
Exclusion Criteria:
- Age <18-years-old.
- Active metastases.
- Other malignancy within five years, unless the probability of recurrence of the prior
malignancy is <5%. Patient's curatively treated for squamous and basal cell carcinoma
of the skin or patients with a history of malignant tumor in the past that have been
disease free for at least five years are also eligible for this study.
- History of organ transplant.
- Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
- Subjects taking chronic systemic corticosteroid therapy for any reason are not
eligible. Subjects may receive steroids as prophylactic anti-emetics, not to exceed
10 mg Decadron weekly. Subjects may also receive pulse doses for Gemcitabine
hypersensitivity, not to exceed Decadron 8 mg BID x 3 days prior to start day of
Gemcitabine. Subjects receiving inhaled or topical corticosteroids are eligible.
Subjects who require chronic systemic corticosteroids after beginning vaccination,
will be removed from study.
- Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or
significant ventricular arrhythmias within the last six months.
- Active infection or antibiotics within 1-week prior to study, including unexplained
fever (temp > 38.1C).
- Autoimmune disease (e.g., systemic lupus erythematosis (SLE), rheumatoid arthritis
(RA), etc.). Patients with a remote history of asthma or mild active asthma are
eligible.
- Other serious medical conditions that may be expected to limit life expectancy to
less than 2 years (e.g., liver cirrhosis) or a serious illness in medical opinion of
the clinical investigator.
- Any condition, psychiatric or otherwise, that would preclude informed consent,
consistent follow-up or compliance with any aspect of the study (e.g., untreated
schizophrenia or other significant cognitive impairment, etc.).
- A known allergy to any component of the vaccine or cell lines.
- Pregnant or nursing women due to the unknown effects of vaccination on the developing
fetus or newborn infant. (For patients with child bearing potential, a βHCG must be
completed within 7 days of first vaccination).

NCT ID:

NCT00614601

Primary Contact:

Study ChairCharles J. Link, M.D.NewLink Genetics Corporation

Backup Contact:

N/A

Location Contact:

Louisville, Kentucky 40292United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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